ArtUs
K-Number: K211248 · 2022-02-11
ApplicantTelemed
Decision Date2022-02-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
ArtUs is a medical device manufactured by Telemed. It received FDA 510(k) clearance on 2022-02-11 under approval number K211248. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ArtUs?
ArtUs is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Telemed. The 510(k) number is K211248.
When was ArtUs approved by the FDA?
ArtUs received FDA 510(k) clearance on 2022-02-11, under approval number K211248.
What company makes ArtUs?
ArtUs is manufactured by Telemed.
What is the FDA product code for ArtUs?
The FDA product code for ArtUs is IYN.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.